Manuals Mandatory! New EU Legislation for Electrical Appliances Matthias Schulz, Erkelenz AXELENT ProfiServices www.axelentsafety.de
28 Countries, One Market, Common Rules What s ahead Short introduction to EU policies New Legislative Framework 8 new EU directives Requirements - Responsibilities of importers and distributors - Risk assessment - Safety notes and warnings in manuals for the EU Page 2
The Purpose of CE Marking Rolls and Key Obligations Objectives Do away with technical barriers to free trade (free market inside EU) Uniform level of minimum safety requirements Rolls and key obligations EU: Define minimum safety requirements in EC/EU directives National Governments: Transform EC/EU directives to national laws Manufacturers: Select and apply all applicable EC/EU directives Issue technical file to proof conformity Market surveillance authorities: Monitoring of application, corrective action in case of breach Page 3
Key Product Ranges Current and Future EC/EU Directives Applicable to Directive To be applied as of Machinery 2006/42/EC 29.12.2009 amended by 2009/127/EC 15.12.2011 EMC 2004/108/EC 20.07.2007 (electromagn. compatibility) 2014/30/EU 20.04.2016 Low voltage 2006/95/EC 16.01.2007 (electrical appliances) 2014/35/EU 20.04.2016 Pressure equipment 97/23/EC 29.05.2002 2014/68/EU 19.07.2016 Explosion protection 94/9/EC 30.06.2003 (ATEX) 2014/34/EU 20.04.2016 Ecological design 2009/125/EC 25.11.2011 Page 4
NLF-Directives (New Legislative Framework) Low Voltage Directive (2014/35/EU) Applicable to all devices operating between 50 and 1000 VAC or 75 and 1500 VDC Key requirements ensure electrical safety by technical measures (no contact with live parts; short-circuit, over-voltage and over-current protection) perform risk assessment, add measures if needed perform and document internal production control edit technical file issue instructions for use CE mark and issue declaration of conformity Page 5
NLF-Directives (New Legislative Framework) EMC Directive (2014/30/EU) Applicable to all devices that can cause electromagnetic interferences or can malfunction when subjected to interferences that is, practically all electric/electronic devicess Key requirements ensure by technical measures that other devices are not interfered with, ensure sufficient immunity to interference perform risk assessment, add measures if needed perform EMC testing edit technical file perform and document internal production control issue instructions for use CE mark and issue declaration of conformity Page 6
Generic Requirements needing Clarification Manufacturers shall ensure that the apparatus is accompanied by instructions and the information referred to in Article 18 in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such instructions and information, as well as any labelling, shall be clear, understandable and intelligible. Article 18 Information Concerning the Use of Apparatus Precautions that must be taken during assembly, installation, maintenance and use (to ensure it is/remains EM compatible) If product is not suitable for use in residential areas, this shall be clearly indicated. Limits of use shall be defined Define intended use of product in the instructions and give all information needed to achieve Page 7
Generic Requirements needing Clarification Minimum Information for EMC Products Questions What is a language understood? National governments decide (Germany: German, Italy: Italian ) What is clear, understandable, intelligible? Terminology? Sentence structures, illustrations, order of information... What are the minimum contents of the instructions? Which precautions could be meant? What defines the limits of a residential area? Which information belongs in the intended use European (mostly ISO/IEC) Standards are used to clarify requirements and provide details. These are not laws. Page 8
Standardisation Programmes in IEC and ISO Type A/1 Basic Standards Basic rules for the respective field/product group Type B/2 Generic Standards Settling specific problems, determining limit values, describing methods Type C/3 Product Standards Listing product specific requirements safety marking, labelling, minimum content of instructions Horizontal Standards, applying to different fields/industry branches for instance IEC 82079-1 for instructions for use Page 9
Determining minimum Contents of Manuals for Household Appliances Research applicable directives, look for requirements on instructions Low voltage directive 2014/35/EU, Article 6, par. 7 contains basic requirements EMC directive 2014/30/EU, Article 18 contains details Research for applicable standards, look for requirements on instructions IEC 60335-1 Household appliances, electric safety (JIS C 9335-1) What? Page 10 Chapter 7 contains rules for instruction manuals of electric household applicances IEC 60335-2-5 Dish-Washers (JIS C 9335-2-5) Chapter 7 contains additional specific rules for dish washers IEC 82079-1 Preparation of instructions How? for use Contains rules for presentation of manuals (readability, safety-related information ) Create checklist containing all relevant requirements Checklists allow research and check-up. They simplify update upon change of rules.
Requirements upon Economic Operators Concerning Instructions for Use Manufacturer Authorised Reprensentative (e. g. subidiary in EU country) Importer Distributor Shall ensure that the apparatus is accompanied by instructions in a language which can be easily understood by consumers and other endusers, as determined by the Member State concerned. Perform those tasks in connection with CE-Marking and Conformity that have been assigned to him by the manufacturer, e. g. Translation Ensure that apparatus is accompanied by instructions and the information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Verify that apparatus is accompanied by the required instructions in a language which can be easily understood by consumers and other end-users in the respective Member State Edit, translate (if manufacturer is based in EU) Translate to EUlanguages and make available Translate to relevant EU-languages and make available Check availability in relevant language(s) Page 11
Risk Assessment now Required by EMC and Low-Voltage Directive Requirement in Annex II of EMC-directive: 3. The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the apparatus conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). Applicable methods Task Based Risk Assessment (EN ISO 12100, chapter 5) Failure Mode and Effects Analysis (IEC 60812 FMEA) Event Tree Analysis (IEC 62502 ETA) Fault Tree Analysis (IEC 61025 FTA) Page 12
Task-Based Risk Assessment A truly meaningful approach Phase of Life and Task Hazard Situation Hazard and Cause Protective Measures, Requirements Semi-automatic operation: 1. Insert workpiece Press ram moves down and crushes person Approach of moving element to fixed part: crushing, sheering Lightcurtain and twohand control meeting Annex I, 1.3.7 A truly meaningful approach: I ll tell you a situation (one by one through all phases of life) and you ll tell me the problems, occurring therein then you ll choose a solution meeting the requirements of Annex I Advantages Streamlined easy process from situation to problem to solution Complete detection of all hazards Page 13
Task-Based Risk Assessment Example: Determening hazards Phase of life Hazard Situation Safety measures 4 Operation: 4.1 Insert part, start crushing, shearing, impact If somebody enters the motion range of axes, while they are moving, he will be injured. Risk estimation S F P PL r Reasons for estimate Page 14
Task-Based Risk Assessment Example: Estimating Risk Phase of life Hazard Situation Safety measures 4 Operation: 4.1 Insert part, start crushing, shearing, impact If somebody enters the motion range of axes, while they are moving, he will be injured. Risk estimation S F P PL r Reasons for estimate 2 2 1 d S: very severe injury. loss of limb F: frequent access for insertion of parts P: hazard known, high speed, user presses button Impact by parts ejected If a workpiece or the mould breaks, or if the workpiece is lost because of deficient clamping pressure, parts may be ejected at high speed. 2 1 2 d S: severe injury F: infrequent P: random event without any influence on part of user Page 15
Task-Based Risk Assessment Example: Selecting Safety Measures Phase of life Hazard Situation Safety measures 4 Operation: 4.1 Insert part, start crushing, shearing, impact Impact by parts ejected If somebody enters the motion range of axes, while they are moving, he will be injured. If a workpiece is lost because of deficient clamping pressure, parts will be ejected. Install light curtain with 14 mm resolution on the operating side. (Meets Annex I 1.3.7, EN ISO 12100 6.2.3.x an ISO 13850), Instructions: Add warning and instruction concerning proper use of light curtain Monitoring of the workpiece clamping pressure Risk estimation S F P PL r Reasons for estimate 2 2 1 d S: very severe injury. loss of limb F: frequent access for insertion of parts P: hazard known, high speed, user presses button 2 1 2 d S: severe injury F: infrequent P: random event without any influence on part of user Page 16
Why is Risk Assessment so Important for Manuals? Risk assessment will answer these questions Which guards and safety devices protect from which hazards? - Describe these in the manual Which applications are hazardous and must be avoided? - Forbid these in the manual Which residual risks remain? - Warn of these in the manual How can the user protect himself against the residual risks? - Describe safe procedures in the manual Risk assessment forms the basis of all safety-related information provided in manuals. Page 17
New EU-Legislation Summary Progressive standardisation of procedures All directives use key-terms the same way One declaration of conformity for all directives Uniform requirements upon manufacturer, importer and distributor Safety in focus risk assessment Formal risk analysis or assessment are now required by all key directives Aids in designing truly safe products Important source information for drafting of manuals What to do? Update know-how of procedures (now!) Get ready for new market rules until early 2016 Page 18
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